Death by Medicine, Revisited – Part III

Medically Induced Death: The Equivalent of Seven Jumbo Jets Falling Out of the Sky Each Day

Never before have complete statistics on the multiple causes of iatrogenesis been combined in one book. Medical science amasses tens of thousands of papers annually, each representing a tiny fragment of the whole picture. To look at only one piece and try to understand the benefits and risks is like standing an inch away from an elephant and trying to describe everything about it. You have to step back to see the big picture, as we have done here. Each specialty, each division of medicine, keeps its own records and data on morbidity and mortality. We have now completed the painstaking work of reviewing thousands of studies and putting the pieces of the puzzle together.

Is American Medicine Working?

US healthcare spending reached $3.5 trillion in 2017, representing 18% of the nation’s gross national product.1 Considering this enormous expenditure, we should have the best medicine in the world. We should be preventing and reversing disease, and doing minimal harm. Careful and objective review, however, shows we are doing the opposite. Because of the extraordinarily narrow, technologically driven context in which contemporary medicine examines the human condition, we are completely missing the larger picture.

Medicine is not taking into consideration the following critically important aspects of a healthy human organism:
■ stress, and how it adversely affects the immune system and life processes;
■ insufficient exercise;
■ excessive calorie intake;
■ highly processed and denatured foods, grown in denatured and chemically damaged soil; and
■ exposure to tens of thousands of environmental toxins.

Instead of minimizing these disease-causing factors, we cause more illness through medical technology, diagnostic testing, overuse of medical and surgical procedures, and overuse of pharmaceutical drugs. The huge disservice of this therapeutic strategy is the result of little effort or money being spent on preventing disease, as evidenced by efforts to curtail use of effective vitamins and supplements.

Then-Congressional Budget Director Peter Orszag made headlines in 2009 when he claimed the US spends $700 billion on unnecessary medical tests. “The unreasonably high cost of healthcare in the United States is a deeply entrenched problem that must be attacked at its root,” he wrote in a Progressive Policy Institute (PPI) report.2 Researchers have demonstrated that if anything, he didn’t go far enough: a Reuters report released later that year found the number could be closer to $850 billion,3 while a 2012 RAND Corporation study found that up to $1.263 trillion of healthcare spending was wasted yearly.4 In addition to administrative complexity, pricing and delivery failures, and out-and-out fraud, “overtreatment” tops these reports’ list of what’s causing the waste. Moreover,

“Some medical experts say the American devotion to the newest, most expensive technology is an important reason that the United States spends much more on healthcare than other industrialized nations. . . without providing better care. [A] Rand Corporation study estimated that one- third or more of the care that patients in this country receive could be of lit- tle value. If that is so, hundreds of billions of dollars each year are being wasted on superfluous treatments.
[There is] a much larger trend in American medicine…A faith in innovation, often driven by [quick] financial incentives, encourages American doctors and hospitals to adopt new technologies even without proof that they work better than older techniques…The problem is not that newer treatments never work. It is that once they become available, [too often prematurely,] they are often used indiscriminately, in the absence of studies to determine which patients they will benefit…And sometimes, the new technologies prove harmful. [Some] doctors in private practice who own their [CT] scanners, use the tests aggressively . . . [as if it were] a new toy in the office5

—endangering asymptomatic patients for whom the scan may be inappropriate.

Health Insurance

To determine whether american medicine is working, we also need to know if enough people have access to the American healthcare system. About 28 million Americans, or 15.5 percent of the population under the age of 65, were without health insurance in 2017, the latest government data available.”6 7

The number of uninsured children in 2017 was 3.9 million—5 percent of all children in the US.8 The large majority of the uninsured (69.2 percent) are native or naturalized citizens.9

The number of uninsured rose 4 million between 2016 and 2018, creeping back up after the steady decline set in motion by the passage of the Affordable Care Act in 2010.10

A study found that 28 percent of working adults who had health insurance were “underinsured” with coverage so meager they often postponed medical care because of costs. Nearly 50 percent overall, and 52 percent of people with health coverage said they had medical bill problems, and 45 percent had foregone needed healthcare due to costs. More than 56 percent of the underinsured receive their coverage through an employer. Nearly half (47 percent) of those who had problems paying their medical bills had used up their savings doing so, and 40 percent said they received a lower credit rating because of those bills.11

Compounding the problem is the issue of insurance fraud. When doctors bill for services they do not render, advise unnecessary tests, or screen everyone for a rare condition, they are committing insurance fraud. The US GAO estimated that $36.7 billion was lost to fraudulent or unnecessary claims in 2017,12 and reclaimed $2.6 billion in judgments that year.13

Underreporting of Iatrogenic Events

As little as 5% and no more than 20% of iatrogenic events are ever reported.14 15 16 17 This implies that if medical errors were completely and accurately reported, we would have an annual iatrogenic death toll much higher than the 987,507 figure we arrived at earlier. In 1994, Leape said his figure of 180,000 medical mistakes resulting in death annually was equivalent to three jumbo jet crashes every two days.18 Our considerably higher figure is equivalent to seven jumbo jets falling out of the sky each day.

What we must deduce from this report is that medicine is in need of complete and total reform—from the curriculum in medical schools to protecting patients from excessive medical intervention. It is obvious that we cannot change anything if we are not honest about what needs to be changed. This report simply shows the degree to which change is required.

We are fully aware of what stands in the way of change: powerful pharmaceutical and medical technology companies, along with other powerful groups with enormous vested interests in the business of medicine. They fund medical research, support medical schools and hospitals, and advertise in medical journals. With deep pockets, they entice scientists and academics to support their efforts. Such funding can sway the balance of opinion from professional caution to uncritical acceptance of new therapies and drugs. You have only to look at the people who make up the hospital, medical, and government health advisory boards to see conflicts of interest.

For example, a 2003 study found that nearly half of medical school faculty who serve on institutional review boards (IRBs) to advise on clinical trial research also serve as consultants to the pharmaceutical industry.19 The study authors were concerned that such representation could cause potential conflicts of interest. In a news release, Dr. Erik Campbell, the lead author, wrote, “Our previous research with faculty has shown us that ties to industry can affect scientific behavior, leading to such things as trade secrecy and delays in publishing research. It’s possible that similar relationships with companies could affect IRB members’ activities and attitudes.”20 The public is mostly unaware of these interlocking interests.

A 2014 study examining the prevalence of IRB members with life science industry connections found about a third (32.1 percent) had some kind of industry relationship. One in ten respondents felt pressure from their department or institution to approve a protocol, and a quarter of respondents admitted to voting on a protocol even when they had a conflict of interest.21

Government medical advisors play a role in adequate reporting of iatrogenic events. The FDA announced in March 2007:

“Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules . . . for the FDA’s powerful advisory committees. Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions. A “significant number” of
the agency’s present advisers would be affected by the new policy, said the FDA acting deputy commissioner, Randall W. Lutter, though he would not say how many.”22

The First Study of Iatrogenesis

Dr. Lucian Leape opened medicine’s Pandora’s box in his 1994 paper, “Error in Medicine,” which appeared in the Journal of the American Medical Association (JAMA). He noted that Schimmel reported in 1964 that 20% of hospital patients suffered iatrogenic injury, with a 20% fatality rate. In 1981, Steel reported that 36% of hospitalized patients experienced iatrogenesis, with a 25% fatality rate, and adverse drug reactions were involved in 50% of the injuries. In 1991, Bedell reported that 64% of acute heart attacks in one hospital were preventable and were mostly due to adverse drug reactions.23

Leape focused on a Harvard Medical Practice Study published in 1991 which found a 4% iatrogenic injury rate for patients, with a 14% fatality rate, in 1984 in New York State.24

From the 98,609 patients injured and the 14% fatality rate, he estimated that in the entire US, 180,000 people die each year partly as a result of iatrogenic injury.

Why Leape chose to use the much lower figure of 4% injury for his analysis remains in question. Using instead the average of the rates found in the three studies he cites (36%, 20%, and 4%) would have produced a 20% medical error rate. The number of iatrogenic deaths using an average rate of injury and his 14% fatality rate would be 1,189,576.

Leape acknowledged that the literature on medical errors is sparse and represents only the tip of the iceberg, noting that when errors are specifically sought out, reported rates are “distressingly high.” He cited several autopsy studies with rates as high as 35–40% of missed diagnoses causing death. He also noted that an intensive care unit reported an average of 1.7 errors per day per patient, and 29% of those errors were potentially serious or fatal.

Leape calculated the error rate in the intensive care unit study. First, he found that each patient had an average of 178 “activities” (staff/ procedure/medical interactions) a day, of which
1.7 were errors, which means a 1% failure rate. This may not seem like much, but Leape cited industry standards showing that in aviation, a 0.1% failure rate would mean two unsafe plane landings per day at Chicago’s O’Hare International Airport; in the US Postal Service, a 0.1% failure rate would mean 16,000 pieces of lost mail every hour; and in the banking industry, a 0.1% failure rate would mean 32,000 bank checks deducted from the wrong bank account.

At the same time, Leape acknowledged the lack of reporting of medical errors. Medical errors occur in thousands of different locations and are perceived as isolated and unusual events. But the most important reason that the problem of medical errors is unrecognized and growing, according to Leape, is that doctors and nurses are unequipped to deal with human error because of the culture of medical training and practice.

Doctors are taught that mistakes are unacceptable. Medical mistakes are therefore viewed as a failure of character and any error equals negligence. No one is taught what to do when medical errors do occur. Leape cites McIntyre and Popper, who said the “infallibility model” of medicine leads to intellectual dishonesty with a need to cover up mistakes rather than admit them.

There are no Grand Rounds on medical errors, no sharing of failures among doctors, and no one to support them emotionally when their error harms a patient. Leape hoped his paper would encourage medical practitioners “to fundamentally change the way they think about errors and why they occur.”

It has been more than two decades since this groundbreaking work, but the mistakes continue to pile up, and it’s debatable whether methods for detecting and tracking them have improved.

In a 2017 survey conducted by the University of Chicago in partnership with the Lucian Leape Institute, more than one fifth of Americans reported they had personally experienced a medical error, and 31% reported they had been involved in caring for someone who experienced an error. The most commonly-cited reason for the error given (out of a list of 23 factors) was “healthcare providers who do not pay attention to detail.” The most common errors involved diagnoses, with 59% of respondents reporting either a failure to diagnose, an incorrect diagnosis or a delayed diagnosis. Even then, only 45% of those who experienced an error notified medical personnel! Asked how patient safety had improved over the past five years, 39% of respondents said it had stayed the same, and 29% reported improvement, but 12% claimed it had gotten worse.25

A 2008 study found as many as half of adverse events reported by patients did not make it into their hospital charts,26 while another conducted that year found patients were aware of three times as many medical errors in their treatment as doctors had recorded in their charts.27

As of 2017, studies continue to find that less than 10% of medical errors are reported.28 This number varies depending on the specialty – a 2008 study found that almost two thirds of cardiologists had recently refused to report a serious error they had direct personal knowledge of to an authority. 29

The Patient and Family Relations error reporting model has shown some promise, providing a novel perspective and valuable context by soliciting “second opinions” from those close to the patient. PFR reports demonstrated little overlap with standard error-reporting models when compared to AHRQ reporting in a 2017 study.30

Leape’s own NPSF recommends the creation of “safety data sets” at multiple levels – department, institution, system, state, and national – to catch errors and identify their cause.31

Dr. John T. James, whose 2013 paper in the Journal of Patient Safety calculated 440,000 deaths yearly from inpatient medical errors, founded his own patient advocacy group, Patient Safety America, after losing his son to medical incompetence in 2002. PSA lobbies for a “Patient Bill of Rights” – a dramatic expansion of informed consent in which patients are entitled to absolute transparency regarding their medical records, itemized and fully explained billing, the track record of the facility and doctors treating them, and the success rate of any procedure or drug treatment (as well as its possible adverse effects).32

Only a Fraction of Medical Errors Are Reported

“If the medical system were a bank, you wouldn’t deposit your money here, because there would be an error every one-in-two to one-in-three times you made a transaction.”
— Stephen Persell, MD, Northwestern University’s Feinberg School of Medicine33

In 1994, Leape said he was well aware that medical errors were not being reported.34 A study conducted in two obstetrical units in the UK found that only about one quarter of adverse incidents were ever reported, to protect staff, preserve reputations, or for fear of reprisals, including lawsuits.35

An analysis by Wald and Shojania found that only 1.5% of all adverse events result in an incident report, and only 6% of adverse drug events are identified properly. The authors learned that the American College of Surgeons estimates that surgical incident reports routinely capture only 5–30% of adverse events. In one study, only 20% of surgical complications resulted in discussion at morbidity and mortality rounds.36 From these studies, it appears that all the statistics gathered on medical errors may substantially underestimate the number of adverse drug and medical therapy incidents. They also suggest that our statistics concerning mortality resulting from medical errors may be in fact conservative figures.

An article in Psychiatric Times (April 2000) outlines the stakes involved in reporting medical errors. The authors found that the public is fearful of suffering a fatal medical error, and doctors are afraid they will be sued if they report an error.37 This brings up the obvious question: who is reporting medical errors? Usually it is the patient or the patient’s surviving family. If no one notices the error, it is never reported. Janet Heinrich, an associate director at the US General Accountability Office responsible for health financing and public health issues, testified before a House subcommittee hearing on medical errors that “the full magnitude of their threat to the American public is unknown” and “gathering valid and useful information about adverse events is extremely difficult.” She acknowledged that the fear of being blamed, and the potential for legal liability, played key roles in the underreporting of errors.

The Psychiatric Times noted that the AMA strongly opposes mandatory reporting of medical errors.38 If doctors are not reporting, what about nurses? A survey of nurses found that they also fail to report medical mistakes for fear of retaliation.39

Indeed, a 2008 study of the reporting practices of hospital personnel found that more than half of error reports came from “other hospital employees” that were not doctors or nurses. Doctors were more likely to report more severe adverse events, but their reports comprised only 1.1 percent of the total.40

No Improvement in Error Reporting

A 2003 survey is all the more distressing because there seemed to be no improvement in error reporting, even with all the attention given to this topic following the publication of Leape’s study and the Institute of Medicine’s widely-published “To Err is Human” report. Dr. Dorothea Wild surveyed medical residents at a community hospital in Connecticut and found that only half were aware that the hospital even had a medical error-reporting system, and that the vast majority did not use it at all. Dr. Wild says this does not bode well for the future. If doctors do not learn error reporting in their training, they will never use it. Wild adds that error reporting is the first step in locating the gaps in the medical system and fixing them.41

Peer-review error reporting systems can and do fail spectacularly, as was the case at Redding Medical Center from 1992 to 2002. A 2008 investigation revealed that the directors of the cardiology and cardiac surgery programs at the hospital completely blocked peer review in those programs, permitting at least 600 patients to undergo unnecessary bypass and valve surgery – procedures which caused hundreds of injuries and deaths. Redding’s unusually high rates of coronary bypass operations and catheterizations were known to both federal and state officials and even reported annually in the Dartmouth Atlas of Health Care, and outside physicians had filed seven complaints with the California Medical Board based on findings from patients mistreated at Redding Medical Center, yet it was not until a “skeptical heart patient” contacted the FBI independently that anyone bothered to investigate.

In their report to Congress on the Redding disaster, Drs. Gerald Rogan, Frank Sebat and Ian Grady denounced the hospital peer-review process and associated legal checks and balances as “so riddled with crippling flaws and the legislation governing the federal and state regulatory agencies so inadequate that prompt amendment of laws and regulations to protect the public is imperative.” Rogan and his colleagues claimed in their report that existing peer review processes actually penalize reviewers, who lose referrals (and trust) from colleagues they review negatively and may be blackballed by hospital administration if a doctor they review negatively is a strong revenue generator.

Analyzing the National Practitioner Data Bank, they found that peer review’s failure was so pervasive that moderate- and high-culpability physician events were eight times more likely to be reported through malpractice awards than through peer review actions! Lawsuits from damaged patients also greatly exceeded peer review reports.

The Redding committee recommended stricter penalties for peer review failures. “Government regulators rarely revoke a hospital’s license or provider status and have no intermediate penalties to tip the balance toward peer review. For peer review to work, the penalties for not doing it must exceed the benefits […] Centers for Medicare and Medicaid Services must impose penalties severe enough to ensure that peer review is not profitable to suppress,” they wrote. Other suggestions included independent and/or anonymous peer review, improving communication between agencies, and the establishment of a National Patient Safety Board – a suggestion Leape has also made.42

The Agency for Healthcare Research and Quality (AHRQ) reports that a 2004 study in Pediatrics discovered that most medical errors made by nurses and physicians treating children are never reported.43 44 Dr. John T. James, whose Patient Safety America advocates for expanded transparency and accountability in medical care, says the former president of the American Board of Medical Specialties personally told him that even patients themselves are only aware of 1% of the medical errors they suffer.45 Less than 5% of patients who die in hospitals are even autopsied – doctors worry they may reveal malpractice, insurers won’t pay for them, and hospitals are not even required to offer – let alone perform – them. As a result, patients regularly take diagnostic errors with them to the grave. A 2002 AHRQ review found one in four autopsies uncovered a major error – either in diagnosis or in underlying cause of death – and 10% revealed an error that could have caused the patient’s death.46

On February 17, 2008, Indiana University School of Medicine aired a revealing radio interview with Lauris Kaldjian, MD, PhD, of the Dept. of Internal Medicine and Program in Biomedical Ethics at the University of Iowa’s Roy J. and Lucille A. Carver College of Medicine.

“Let’s say you’re a doctor—a heart surgeon. And you make a mistake. Maybe you prescribe the wrong medicine.
Maybe you cut something you’re not supposed to. And it might not be a big deal. But then again, it might. The question is: do you admit your mistake and report it to the higher ups?”
Lauris Kaldjian directs the bioethics program at the University of Iowa. According to his recent study, the answer to that question is probably no. Most doctors he surveyed agree in theory that’s it’s a good thing to report medical errors. But few actually do it.47

Public Suggestions on Iatrogenesis

In a telephone survey conducted by the Harvard School of Public Health, 1,207 adults ranked the effectiveness of the following measures in reducing preventable medical errors that result in serious harm. Following each measure is the percentage of respondents who ranked the measure as “very effective.”
■ Giving doctors more time to spend with patients (78%)
■ Requiring hospitals to develop systems to avoid medical errors (74%)
■ Better training of health professionals (73%)
■ Using only doctors specially trained in intensive care medicine on intensive care units (73%)
■ Requiring hospitals to report all serious medical errors to a state agency (71%)
■ Increasing the number of hospital nurses (69%)
■ Reducing the work hours of doctors in training to avoid fatigue (66%)
■ Encouraging hospitals to voluntarily report serious medical errors to a state agency (62%)48

Various initiatives are under way to address these problems. The Patient Safety and Quality Improvement Act of 2005 “was enacted in response to growing concern about patient safety in the United States. The goal of the Act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.”49 The law created Patient Safety Organizations (PSOs) tasked with collecting and analyzing confidential information reported by healthcare providers – groups that provided legal privilege and confidentiality protection to any information aggregated for patient safety purposes. The AHRQ reported it had listed 81 organizations as PSOs by the end of 2014. 50

A new specialty in modern medicine that is developing in part from the focus on the need for improved quality of hospital care is Hospital Medicine. It trains physicians as “hospitalists” to devote themselves to the safety of hospital patients. These would be the doctors referred to above who are “specially trained in intensive care medicine on intensive care units.” These would also be the physicians who are there to relieve doctors in training, which would allow doctors’ shifts to be reduced in order to combat fatigue and reduce errors. In 2009, The American Board of Hospital Medicine (ABHM) was founded as the first board of certification for Hospital Medicine in North America. The specialized training of “hospitalists” and the increase in their future numbers may enable them to spend more time with patients, which appears to be a priority with the public. There are also campaigns to increase the number of hospital nurses and to educate them regarding hospital errors.

A systematic review of studies focusing on nurses’ error-reporting practices found that barriers to reporting included fear of being investigated or held responsible, negative reactions from the person in charge or peers, impacts on time and workload, and a lack of understanding regarding the benefits of reporting near-misses. Many studies have recommended the adoption of anonymous, uncomplicated, and efficient reporting systems that stress the reporting of near-misses in addition to errors that cause harm as a valuable tool in reducing iatrogenesis.51 52
NOTES: